NCT07359625

Effects of Ketone Bodies on Insulin Sensitivity

KETO-SENSE - Effects of Ketone Bodies on Insulin Sensitivity

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 55 Years – 70 Years
• Healthy volunteers: Accepted

Summary

KETO-SENSE is a clinical research study investigating how ketone bodies affect energy metabolism and insulin sensitivity in humans. Ketone bodies are naturally produced by the liver during fasting or prolonged exercise and can serve as an alternative fuel for the brain, heart, and muscles. In this study, ten overweight but otherwise healthy adults aged 55-70 years will participate in four study days at Aarhus University Hospital. Participants will receive one of four interventions in a randomized crossover design: 1) growth hormone (GH) and a ketone supplement, 2) GH and placebo, 3) a saline infusion with the ketone supplement, or 4) placebo (saline infusion and placebo supplement). The study uses advanced PET/CT imaging, indirect calorimetry, and tissue biopsies to measure how ketones influence fat breakdown, glucose uptake, and energy expenditure. By understanding these mechanisms, the study aims to clarify whether oral ketone supplementation can improve insulin sensitivity and energy metabolism - findings that could be relevant for common conditions such as overweight, insulin resistance, and type 2 diabetes.

Conditions

• Insulin Resistance
• Obesity & Overweight
• Energy Metabolism
• Ketone Body Metabolism

Interventions

Type	Name	Description
DRUG	Growth Hormone, Human	Continuous intravenous infusion of growth hormone (30 ng·kg-¹·min-¹) for approximately 7 hours to induce physiological lipolysis.
DIETARY_SUPPLEMENT	Oral ketone supplement (KetoAid®, KE4)	Oral administration of D-β-hydroxybutyrate ester (R-1,3-butanediol β-hydroxybutyrate).
DRUG	Saline infusion (placebo)	Continuous IV infusion of isotonic saline as placebo for growth hormone.
DIETARY_SUPPLEMENT	Oral placebo drink	Oral administration of an isocaloric placebo drink.

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Denmark